9106 RESULTS
COMMENT This work increases our understanding of how trafficking regulation is essential for neuronal function, especially regarding GGA3 in neurons. GGAs are clathrin and ARF-binding proteins that typically help sort proteins from the trans-Golgi network to ...
COMMENT This is a highly interesting and technically well-controlled study, convincingly demonstrating how GGA3-mediated changes in BACE1 trafficking lead to axonal damage, which also happens early in AD pathogenesis. This new study is the latest in a series from ...
COMMENT Suárez-Calvet et al. report the promising performance of novel p-tau assays in cerebrospinal fluid to detect early changes of tau phosphorylation due to amyloid pathology. They monitored a new combination of antibodies capturing different lengths (N-ter ...
COMMENT I think this is a truly exciting development for AD diagnostics! We now need to develop appropriate use criteria to avoid misuse and misinterpretation of new blood tests for diagnosis of Alzheimer’s disease, similar to what has already been done for CSF ...
COMMENT Congratulations to Randy Bateman and his Washington University colleagues for the initial development of this assay and to Joel Braunstein and his C2N colleagues for doing the work needed to introduce its use in the clinical setting! It is an important ...
COMMENT Early termination of studies 301 and 302 and a dose increase midway through the trial led to an incomplete dataset and clearly complicate the interpretation of the results. However, the totality of the data provides evidence of dose-related lowering of ...
COMMENT The FDA advisory committee meeting held on November 6, 2020, yielded an overall negative view by the committee members of the aducanumab submission. The meeting itself, however, was not able to discuss adequately the most pertinent issues given the ...
COMMENT It’s an interesting hypothesis, but more especially for Parkinson’s disease (PD) than AD. The pathogenesis of vitiligo encompasses both melanocyte vulnerability and autoimmunity by interferon-γ-producing, melanocyte-specific CD81 T cells, and melanized ...
COMMENT Multiple issues in this clinical program make assessing aducanumab’s efficacy difficult. Many of these are highly technical from a statistical and clinical perspective. I won’t go into all of them, but will focus on two major points that were also brought ...
COMMENT I am a paid consultant for Biogen, so will not comment directly on the FDA’s deliberation of aducanumab. I raise here some general questions that may have an impact on AD therapeutics going forward as we are all taking stock of where we are with the data ...
COMMENT I agree with Tristan Massie regarding the issues he raised in the statistical section of the FDA/Biogen document, and with David Knopman and colleagues regarding the methodological and clinical issues they raised in their recent article published by ...
COMMENT There are several layers to consider here. Given the contrasting Phase 3 study results, it’s hard to feel confident the active intervention attenuated the rate of decline. Had the negative study not been negative, it would still be important to consider ...
COMMENT I agree with published studies by Knopman and Schneider and colleagues that the current aducanumab trials fail to prove efficacy. I am worried that many stakeholders with good intentions are trying to push this forward, but this is a dangerous path. We ...
COMMENT Like many physicians, physician-scientists, and scientists who work on Alzheimer’s disease, my major goals for our field are to develop treatments that prevent, delay the onset of, or slow the cognitive decline that occurs in AD. In the case of EMERGE and ...
COMMENT The FDA advisory committee meeting and its aftermath have been discouraging. The submitted data is highly challenging, with two interrupted Phase 3 trials yielding discordant results. But the tenor of the meeting and subsequent discussion have generally ...
